Download or read book Rift lines Within European Regulatory Framework for Biosimilars when Taking Heterogeneity and Variation During Lifecycle of the Reference Biologic and the Biosimilar Into Account written by Malik Osmane and published by Anchor Academic Publishing (aap_verlag). This book was released on 2014 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
Download or read book Rift lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account written by Malik Osmane and published by Anchor Academic Publishing (aap_verlag). This book was released on 2014-02-01 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
Download or read book Biosimilars written by Jean-Louis Prugnaud and published by Springer Science & Business Media. This book was released on 2012-11-27 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
Download or read book WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2021-05-06 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: The seventy-second meeting of the WHO Expert Committee on Biological Standardization was held from 19 to 23 October 2020 by WebEx video conferencing due to the restrictions imposed during the coronavirus disease 2019 (COVID-19) pandemic. The meeting was opened on behalf of the Director-General of WHO by Dr Mariângela Batista Galvão Simão, Assistant Director-General, Access to Medicines and Health Products. Dr Simão welcomed Committee members, meeting participants and observers. Dr Simão began by noting that the Committee had met as recently as August 2020, primarily to address standardization activities related to COVID-19, and that much remains to be learnt about the pandemic. The WHO Solidarity Trial was continuing to facilitate the rapid and robust comparison of potential treatments. Recently published interim results indicated that the four small molecule treatments remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon had little or no benefit in terms of overall mortality or speed of recovery of hospitalized patients – to date only dexamethasone had proved to be effective against severe COVID-19.
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by WHO Technical Report. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and revision of WHO Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included WHO guidance on the production and evaluation of the quality, safety and efficacy of monoclonal antibodies as similar biotherapeutic products (SBPs); blood and blood components as essential medicines; estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma; snake antivenom immunoglobulins; human pandemic influenza vaccines in non-vaccine-producing countries; and clinical evaluation of vaccines: regulatory expectations. In addition, the following WHO guidance documents were also adopted: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards; and Human challenge trials for vaccine development: regulatory considerations. One WHO addendum document "Labeling information of inactivated influenza vaccines for use in pregnant women" was also adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above nine WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-10). Finally, all additions and discontinuations made during the 2016 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 11. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Download or read book Building a New Future written by United Nations and published by UN. This book was released on 2021-05-31 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication argues that Latin America and the Caribbean are in a position to move towards a "big push for sustainability" through a combination of economic, industrial, social and environmental policies capable of driving an equal and sustainable recovery and relaunching development in the region. Comprised of five chapters, the publication studies the three crises (slow growth, growing inequality and the environmental emergency) affecting economies and societies around the world, placing particular focus on those of Latin America and the Caribbean. It goes on to present a framework for analysing these crises in an integrated manner and measuring their magnitude in the specified regions. It then examines the quantitative impacts on growth, emissions, income distribution and the external sector under different policy scenarios, highlighting the potential of various policy combinations to forge a more dynamic growth path, with lower emissions and greater equality. Further identifying seven sectors that can drive sustainable development and proposing policies to foster these sectors, the publication concludes with an analysis that links up macroeconomic, industrial, social and environmental policies and the role of the State in building consensus for their implementation.
Download or read book UNESCO science report written by UNESCO and published by UNESCO Publishing. This book was released on 2015-11-09 with total page 818 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are fewer grounds today than in the past to deplore a North‑South divide in research and innovation. This is one of the key findings of the UNESCO Science Report: towards 2030. A large number of countries are now incorporating science, technology and innovation in their national development agenda, in order to make their economies less reliant on raw materials and more rooted in knowledge. Most research and development (R&D) is taking place in high-income countries, but innovation of some kind is now occurring across the full spectrum of income levels according to the first survey of manufacturing companies in 65 countries conducted by the UNESCO Institute for Statistics and summarized in this report. For many lower-income countries, sustainable development has become an integral part of their national development plans for the next 10–20 years. Among higher-income countries, a firm commitment to sustainable development is often coupled with the desire to maintain competitiveness in global markets that are increasingly leaning towards ‘green’ technologies. The quest for clean energy and greater energy efficiency now figures among the research priorities of numerous countries. Written by more than 50 experts who are each covering the country or region from which they hail, the UNESCO Science Report: towards 2030 provides more country-level information than ever before. The trends and developments in science, technology and innovation policy and governance between 2009 and mid-2015 described here provide essential baseline information on the concerns and priorities of countries that could orient the implementation and drive the assessment of the 2030 Agenda for Sustainable Development in the years to come.
Download or read book Pharmaceutical Prices in the 21st Century written by Zaheer-Ud-Din Babar and published by Springer. This book was released on 2014-12-05 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the global pharmaceutical pricing policies. Medicines use is increasing globally with the increase in resistant microbes, emergence of new treatments, and because of awareness among consumers. This has resulted in increased drug expenditures globally. As the pharmaceutical market is expanding, a variety of pharmaceutical pricing strategies and policies have been employed by drug companies, state organizations and pharmaceutical pricing authorities.
Download or read book Trauma and Human Rights written by Lisa D. Butler and published by Springer. This book was released on 2019-07-17 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Human rights violations and traumatic events often comingle in victims’ experiences; however, the human rights framework and trauma theory are rarely deployed together to illuminate such experiences. This edited volume explores the intersection of trauma and human rights by presenting the development and current status of each of these frameworks, examining traumatic experiences and human rights violations across a range of populations and describing efforts to remediate them. Individual chapters address these topics among Native Americans, African Americans, children, women, lesbian/gay/bisexual/transgender individuals, those with mental disabilities, refugees and asylees, and older adults, and also in the context of social policy and truth and reconciliation commissions. The authors demonstrate that the trauma and human rights frameworks each contribute invaluable and complementary insights, and that their integration can help us fully appreciate and address human suffering at both individual and collective levels.
Download or read book A Biotech Manager s Handbook written by M O'Neill and published by Elsevier. This book was released on 2012-05-02 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development
Download or read book Mixed Effects Models for the Population Approach written by Marc Lavielle and published by CRC Press. This book was released on 2014-07-14 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects ModelsMixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whol
Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Download or read book Directory of the Parish of Terrebonne 1897 Containing a Historical Sketch of the Parish Names Addresses and Locations of the Lawyers Doctors Manufacturers Merchants Planters Plantations Managers Mechanics Schools Societies Distances To written by Anonymous and published by Legare Street Press. This book was released on 2023-07-18 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 1897 directory of Terrebonne Parish is a trove of information regarding this region of Louisiana. The volume contains information on lawyers, doctors, local businesses, and local school systems. The directory provides essential information for a researcher, genealogist, or curious reader. This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Download or read book Justice a Poem written by and published by . This book was released on 1774 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Davidson s Principles and Practice of Medicine E Book written by Brian R. Walker and published by Elsevier Health Sciences. This book was released on 2013-12-06 with total page 1394 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than two million medical students, doctors and other health professionals from around the globe have owned a copy of Davidson’s Principles and Practice of Medicine since it was first published. Today’s readers rely on this beautifully illustrated text to provide up-to-date detail of contemporary medical practice, presented in a style that is concise and yet easy to read. Davidson’s provides the factual knowledge required to practise medicine, explaining it in the context of underlying principles, basic science and research evidence, and shows how to apply this knowledge to the management of patients who present with problems rather than specific diseases. The book has won numerous prizes including being highly commended in the British Medical Association book awards. Davidson’s global perspective is enhanced by the input of an international team of authors and a distinguished International Advisory Board from 17 countries. Building on the foundations laid down by its original editor, Davidson’s remains one of the world’s leading and most respected textbooks of medicine. The underlying principles of medicine are described concisely in the first part of the book, and the detailed practice of medicine within each sub-specialty is described in later system-based chapters. Most chapters begin with a two-page overview of the important elements of the clinical examination, including a manikin to illustrate the key steps in the examination of the relevant system. A practical, problem-based clinical approach is described in the ‘Presenting Problems’ sections, to complement the detailed descriptions of each disease. The text is extensively illustrated, with over 1000 diagrams, clinical photographs, and radiology and pathology images. 1350 text boxes present information in a way suitable for revision, including 150 clinical evidence boxes summarising the results of systematic reviews and randomised controlled trials and 65 ’In Old Age’ boxes highlighting important aspects of medical practice in the older population. A combined index and glossary of medical acronyms contains over 10 000 subject entries. The contents can also be searched comprehensively as part of the online access to the whole book on the StudentConsult platform. Access over 500 self-testing questions with answers linked to the book’s content for further reading. The text uses both SI and non-SI units to make it suitable for readers throughout the globe. A new chapter specifically on Stroke Disease recognises the emergence of Stroke Medicine as a distinct clinical and academic discipline. A rationalisation of the 1350 boxes used throughout the book gives a simpler and clearer presentation of the various categories. New ‘In Adolescence’ boxes recognise the fact that many chronic disorders begin in childhood and become the responsibility of physicians practising adult medicine. These boxes acknowledge the overlap ‘transitional’ phase and highlight the key points of importance when looking after young people. The regular introduction of new authors and editors maintains the freshness of each new edition. On this occasion Dr Ian Penman has joined the editorial team and 18 new authors bring new experience and ideas to the content and presentation of the textbook. An expanded International Advisory Board of 38 members includes new members from several different countries.
Download or read book The Magic Drum and Other Favourite Stories written by Sudhā Mūrti and published by Penguin Books India. This book was released on 2006 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: A princess thinks she was a bird, a coconut that cost a thousand rupees, and a shepherd with a bag of words...Kings and misers, princes and paupers, wise men and foolish boys, the funniest and oddest men and women come alive in this sparkling new collection of stories. The clever princess will only marry the man who can ask her a question she cannot answer; the orphan boy outwits his greedy uncles with a bag of ash; and an old couple in distress is saved by a magic drum. Sudha Murty's grandparents told her some of these stories when she was a child; others she heard from her friends from around the world. These delightful and timeless folktales have been her favourites for years, and she has recounted them many times over to the young people in her life. With this collection, they will be enjoyed by many more readers, of all ages. Age group of target audience is 8+.
Download or read book Public Health Mental Health and Mass Atrocity Prevention written by Jocelyn Getgen Kestenbaum and published by Routledge. This book was released on 2021-07-29 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: This multidisciplinary volume considers the role of both public health and mental health policies and practices in the prevention of mass atrocity, including war crimes, crimes against humanity, and genocide. The authors address atrocity prevention through the framework of primary (pre-conflict), secondary (mid-conflict), and tertiary (post-conflict) settings. They examine the ways in which public health and mental health scholars and practitioners currently orient their research and interventions and the ways in which we can adapt frameworks, methods, tools, and practice toward a more sophisticated and truly interdisciplinary understanding and application of atrocity prevention. The book brings together diverse fields of study by global north and global south authors in diverse contexts. It culminates in a narrative that demonstrates the state of the current fields on intersecting themes within public health, mental health, and mass atrocity prevention and the future potential directions in which these intersections could go. Such discussions will serve to influence both policy makers and practitioners in these fields toward developing, adapting, and testing frames and tools for atrocity prevention. Multidisciplinary perspectives are represented among editors and authors, including law, political science, international studies, public health, mental health, philosophy, clinical psychology, social psychology, history, and peace studies.
